Fujirebio Europe launches iAMP® COVID-19 SANO Assay, a molecular detection assay that can be performed in saliva

Product news

Gent, Belgium – June 16, 2021: Fujirebio Europe today announced the commercial launch of iAMP COVID-19 SANO (Saliva And Nasopharyngeal Oropharyngeal) Assay, a molecular CE-IVD assay from its partner Atila Biosystems, Inc. The test is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal/oropharyngeal swabs and saliva specimen. It is an isothermal assay based on Atila’s proprietary technologies.

“Effective surveillance of the COVID-19 pandemic depends largely on the frequency of testing and the speed of reporting”, said Christiaan De Wilde, CEO of Fujirebio Europe. “This new product can not only be performed in saliva specimen, which makes it a very non-invasive testing solution, it also does not require RNA extraction. This makes the test suitable for mass screening programs, with a processing time from sample collection to result of only 70 minutes”. 

Public healthcare authorities worldwide monitor COVID-19 test performance closely. The iAMP COVID-19 SANO Assay has shown good sensitivity and specificity in recent studies1, with 100% positive predictive agreement (PPA) and 100% negative predictive agreement (NPA) in nasopharyngeal swabs and saliva specimen respectively. 

The new test completes the existing COVID-19 test panel that already is used across the world today to support fast and trustworthy diagnosis. More information can be found at: www.fujirebio.com/covid-19.

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About Fujirebio

Fujirebio is a global leader in the field of high-quality in vitro diagnostics (IVD) testing. It has more than 50 years’ accumulated experience in the conception, development, production and worldwide commercialization of robust IVD products. Fujirebio has a long-lasting tradition for developing high-quality routine and truly novel biomarkers. Its IVD product lines span the range from specialized manual and automated testing to fully automated routine clinical laboratory testing solutions covering a variety of disease states.
Fujirebio’s global presence includes offices in the United States, Latin America, Europe and Asia as well as a vast international distribution network.

About Atila Biosystems, Inc.

Atila Biosystems, Inc. is based in Mountain View, California in the USA and since 2009, Atila Biosystems, Inc. has focused on developing novel chemistry for nucleic acid amplification and detection of clinical diagnostic applications. The team brings deep expertise in biological and chemical engineering as they work to develop innovative technologies with ultra-high multiplex ability, accuracy and speed. The company is at the forefront of the nucleic acid amplification field and has innovative technologies for both isothermal amplification and polymerase chain reaction.